Status:
WITHDRAWN
PRETELL: PREvention of TELomere-related Complications After Lung Transplant
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Short Telomere Length
Lung Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the safety and efficacy of Danzol in lung transplant recipients with short telomeres. Subjects with short telomeres recipient of lung transplant, will be randomized in the first month pos...
Eligibility Criteria
Inclusion
- Age greater than 18
- Ability to give informed consent
- Recipient of lung transplantation
- Short telomeres assessed either pre-transplant or post-transplant with FLOW-FISH as lymphocyte telomere length \<10th percentile predicted for age
- Clinically stable one month after lung transplant
Exclusion
- Patients on androgen hormones to include testosterone or high dose estrogen (estradiol 0.5 mg/day or greater) during 12 months prior to enrollment
- Patients with active thrombosis or thromboembolic disease and history of such events unless thrombosis is line related.
- Undiagnosed abnormal genital bleeding, porphyria, androgen-dependent tumor, or prostatic hypertrophy
- Patients with active hepatitis B or C
- Patients who have received a bone marrow transplant
- Clinically unstable after lung transplantation
- Current pregnancy, or unwillingness to take be on two forms of contraceptives including a barrier method of birth control or practice abstinence to refrain from pregnancy if of childbearing potential during the course of the study
- Lactating women, due to the potentially harmful effects on the nursing child
- Patients with abnormal liver function AST, ALT \>3 times normal
- Subjects with a history of benign intracranial hypertension
- Subjects with a history of liver disease not limited to alcoholic hepatitis/cirrhosis, non-alcoholic steatohepatitis (NASH), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and/or history of hepatic adenoma.
- Subjects with poorly controlled or uncontrolled Type I or II diabetes mellitus
- Significant renal abnormalities GFR\< 40 ml/min/m2
- Significant cardiac dysfunction with ejection fraction less than 50%
- Moribund status such as death is expected in the coming year
- Currently taking carbamazepine, pimozide or lomitapide
- Inability to understand the investigational nature of the study or to give informed consent
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04807309
Start Date
January 1 2021
End Date
January 1 2022
Last Update
February 15 2023
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